Engr 3, Quality

Responsibilities

• Quality System Management:
  • Provide engineering support to maintain a comprehensive quality management system, tailored to the distribution of medical devices and pharmaceuticals.
  • Ensure systems are in line with Good Distribution Practices, ISO13485 and other relevant regulatory standards.
  • Provide statistical data analysis in support of investigations and continuous improvement projects.
  • Lead or participate in qualifying suppliers within calibration, validation or temperature monitoring processes.
• Quality Operations Oversight:
  • Monitor quality control processes in change control, temperature monitoring and validations including implementing continuous improvement strategies.
• Validation and Calibration Expertise:
  • Lead validation efforts for distribution equipment, processes, and software, ensuring accuracy and reliability, including IQ/OQ/PQ protocol writing, execution and approval of protocols.
  • Oversee the calibration of critical instrumentation to maintain precise measurements and controls, including OOT investigations
  • Manage validation vendors to ensure on time calibrations, at multiple sites, of all critical equipment.
• Environmental Monitoring:
  • Monitor Environmental conditions at Distribution Centers to protect product integrity.
  • Implement and manage controls for temperature, humidity, and other critical parameters.
  • Implement and manage shipping lane controls to ensure product integrity is safeguarded throughout the shipping process.
• Audit and Compliance Readiness:
  • Prepare for and support both internal and external audits.
  • Address audit outcomes swiftly and effectively to maintain compliance.
• Quality Incident Investigation:
  • Spearhead investigations into any quality deviations, non-conformances, or customer complaints.
  • Implement corrective actions to prevent recurrence and enhance quality.
  • Directly participate in quality investigations, including owning those investigations to closure.
  • Act as a reviewer and approver of quality investigations

• Document and Change Management:
  • Maintain controlled procedures within calibration, validation, environmental controls, change control and risk management.
  • Ensure data from environmental controls is maintained in centralized repository.
  • Manage change control processes to ensure seamless transitions and compliance.
  • Lead change control process for designated sites.

Required Qualifications:

• Bachelor’s degree in engineering
• 2-3 years of experience in quality engineering, within a distribution center or manufacturing of medical devices or pharmaceuticals.

Preferred Qualifications:

• Master’s degree in engineering
• ASQ CQA or CQE certification
• Experience with Boards of Pharmacy, licensing, and regulatory submissions
• Experience as a designated representative with state boards of pharmacy
• 2-3 years’ experience with ISO 13485, certification preferred

Skills:

• Excellent problem-solving skills with the ability to think critically and creatively.
• Experience working with ERP systems.
• Knowledge of FDA regulations and ISO standards related to medical device manufacturing.
• 2- 3 years’ experience with ISO 13485, certification preferred

Pay Range: 40-45/hr *based on experience